Efficacy and Tolerance Comparison Between Subconjunctival Injection of Triamcinolone and Intravitreal Implant of Dexamethasone for the Treatment of Inflammatory Macular Edema (TRIOZ)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02556424 |
Recruitment Status :
Active, not recruiting
First Posted : September 22, 2015
Last Update Posted : October 27, 2020
|
Tracking Information | |||
---|---|---|---|
First Submitted Date ICMJE | May 29, 2015 | ||
First Posted Date ICMJE | September 22, 2015 | ||
Last Update Posted Date | October 27, 2020 | ||
Actual Study Start Date ICMJE | January 2016 | ||
Estimated Primary Completion Date | December 2020 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Evaluation of the effectiveness of a subconjunctival injection of triamcinolone on reducing the central macular thickness versus an intravitreal implant of dexamethasone between patient selection and 2 months after treatment [ Time Frame: At 2 months after treatment ] Difference of the central macular thickness in the treated eye, measured by Optical Coherence Tomography (OCT) spectral domain, for each patient between patient selection and 2 months after treatment
|
||
Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | |||
Current Secondary Outcome Measures ICMJE |
|
||
Original Secondary Outcome Measures ICMJE |
|
||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Efficacy and Tolerance Comparison Between Subconjunctival Injection of Triamcinolone and Intravitreal Implant of Dexamethasone for the Treatment of Inflammatory Macular Edema | ||
Official Title ICMJE | Efficacy and Tolerance Comparison Between Subconjunctival Injection of Triamcinolone and Intravitreal Implant of Dexamethasone for the Treatment of Inflammatory Macular Edema | ||
Brief Summary | Corticosteroids, whether injected peri- or intra-ocularly, remain indispensable tools of the therapeutic arsenal in treating inflammatory macular edema. However, a few years ago, only triamcinolone acetonide was available to ophthalmologists. This molecule, developed initially for rheumatological or dermatological use, has been increasingly deployed in ophthalmology, while still off-label. In 2011, the delivery system of dexamethasone from biodegradable and injectable implant into the vitreous cavity obtained the label for inflammatory macular edema. This protocol is therefore designed to compare the efficacy and safety of peri- and intra-ocular injections of corticosteroids in the treatment of inflammatory macular edema. |
||
Detailed Description | This research compares the implantation techniques of corticosteroids in the eye, with two groups of equal size being followed. This is a multi-center, controlled study, with the reference drug being the intravitreal implant of 700μg of dexamethasone (Ozurdex®) compared to subconjunctival injection of triamcinolone (Kénacort retard®). This is an open, prospective, randomized study. It is not possible, for technical reasons, to inject blind two products with different injection routes and that are visible to the investigator during control examinations (sub-conjunctival crystals and intravitreal implant). However, the assessment of visual acuity and central macular thickness will be performed by an uninformed ophthalmologist. | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 3 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||
Condition ICMJE | Inflammatory Macular Edema | ||
Intervention ICMJE |
|
||
Study Arms ICMJE |
|
||
Publications * | Couret C, Poinas A, Volteau C, Riche VP, Le Lez ML, Errera MH, Creuzot-Garcher C, Baillif S, Kodjikian L, Ivan C, Le Jumeau de Kergaradec LM, Chiffoleau A, Jobert A, Jaulin J, Biron L, Hervouet E, Weber M. Comparison of two techniques used in routine care for the treatment of inflammatory macular oedema, subconjunctival triamcinolone injection and intravitreal dexamethasone implant: medical and economic importance of this randomized controlled trial. Trials. 2020 Feb 10;21(1):159. doi: 10.1186/s13063-020-4066-0. | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||
Recruitment Information | |||
Recruitment Status ICMJE | Active, not recruiting | ||
Actual Enrollment ICMJE |
114 | ||
Original Estimated Enrollment ICMJE |
142 | ||
Estimated Study Completion Date ICMJE | February 2021 | ||
Estimated Primary Completion Date | December 2020 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||
Sex/Gender ICMJE |
|
||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | France | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT02556424 | ||
Other Study ID Numbers ICMJE | RC15_0056 | ||
Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Responsible Party | Nantes University Hospital | ||
Study Sponsor ICMJE | Nantes University Hospital | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Nantes University Hospital | ||
Verification Date | October 2020 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |